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ABSTRACT: OBJECTIVES.: To evaluate the feasibility and safety of percutaneous closure of complex secundum-type atrial septal defects (ASD) in patients with posterior-inferior rim deficiency. BACKGROUND.: Transcatheter approach is the method of choice for ASD closure, however up to now 20% of the defects are not considered suitable for percutaneous intervention because of the lack of surrounding rims, especially the posterior -inferior. METHODS.: A total of 268 patients were evaluated between March 2005 and April 2011 for ASD closure. Twenty-four patients (9%) were not considered suitable for a percutaneous intervention and referred to surgery due to inadequate rims or a large defect diameter . Out of the remaining 244 patients, 25 (10,2%) had posterior-inferior rim deficiency and represent our study group. RESULTS: After failure of the conventional approach, alternative techniques were attempted. In 16 patients an adjusted deployment and alignment manoeuvre approach was initially successful. In 5 other patients a slide out technique was successfully performed by exploiting the right upper pulmonary vein. Finally in the remaining 4 patients, ASD closure was obtained by completely re-orienting the system with a jugular approach. No peri-procedural complications occurred and at 12-month transesophageal echocardiography evaluation no residual shunt could be detected. CONCLUSIONS.: Our data show the feasibility of percutaneous approach for ASD closure in presence of a deficient posterior-inferior rim. The procedural success is strictly related to correct sizing and demonstration of a balloon notch on fluoroscopy. Long term follow-up supports efficacy of the procedure in these selected cases. © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 08/2012; · 2.29 Impact Factor
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Francesco Pelliccia,
Carlo Trani,
Giuseppe G L Biondi-Zoccai,
Marco Nazzaro,
Andrea Berni,
Giuseppe Patti,
Roberto Patrizi,
Bruno Pironi,
Pietro Mazzarotto, Gaetano Gioffrè,
Giulio Speciale,
Christian Pristipino
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ABSTRACT: It remains undefined if transradial coronary angiography from a right or left radial arterial approach differs in real-world practice. To address this issue, we performed a subanalysis of the PREVAIL study. The PREVAIL study was a prospective, multicenter, observational survey of unselected consecutive patients undergoing invasive cardiovascular procedures over a 1-month observation period, specifically aimed at assessing the outcomes of radial approach in the contemporary real world. The choice of arterial approach was left to the discretion of the operator. Prespecified end points of this subanalysis were procedural characteristics. Of 1,052 patients consecutively enrolled, 509 patients underwent transradial catheterization, 304 with a right radial and 205 with a left radial approach. Procedural success rates were similar between the 2 groups. Compared to the left radial group, the right radial group had longer procedure duration (46 ± 29 vs 33 ± 24 minutes, p <0.0001) and fluoroscopy time (765 ± 787 vs 533 ± 502, p <0.0001). At multivariate analysis, including a parsimonious propensity score for the choice of left radial approach, duration of procedure (beta coefficient 11.38, p <0.001) and total dose-area product (beta coefficient 11.38, p <0.001) were independently associated with the choice of the left radial artery approach. The operator's proficiency in right/left radial approach did not influence study results. In conclusion, right and left radial approaches are feasible and effective to perform percutaneous procedures. In the contemporary real world, however, the left radial route is associated with shorter procedures and lower radiologic exposure than the right radial approach, independently of an operator's proficiency.
The American journal of cardiology 05/2012; 110(6):771-5. · 3.58 Impact Factor
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Journal of Cardiovascular Medicine 04/2011; 12(4):282-4. · 1.51 Impact Factor
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Giornale italiano di cardiologia (2006) 06/2010; 11(6):478-80.
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Christian Pristipino,
Adriana Roncella,
Carlo Trani,
Marco S Nazzaro,
Andrea Berni,
Germano Di Sciascio,
Alessandro Sciahbasi,
Salvatore Donato Musarò,
Pietro Mazzarotto, Gaetano Gioffrè,
Giulio Speciale
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ABSTRACT: To assess: the reasons behind an operator choosing to perform radial artery catheterisation (RAC) as against femoral arterial catheterisation, and to explore why RAC may fail in the real world.
A pre-determined analysis of PREVAIL study database was performed. Relevant data were collected in a prospective, observational survey of 1,052 consecutive patients undergoing invasive cardiovascular procedures at nine Italian hospitals over a one month observation period. By multivariate analysis, the independent predictors of RAC choice were having the procedure performed: (1) at a high procedural volume centre; and (2) by an operator who performs a high volume of radial procedures; clinical variables played no statistically significant role. RAC failure was predicted independently by (1) a lower operator propensity to use RAC; and (2) the presence of obstructive peripheral artery disease. A 10-fold lower rate of RAC failure was observed among operators who perform RAC for > 85% of their personal caseload than among those who use RAC < 25% of the time (3.8% vs. 33.0%, respectively); by receiver operator characteristic (ROC) analysis, no threshold value for operator RAC volume predicted RAC failure.
A routine RAC in all-comers is superior to a selective strategy in terms of feasibility and success rate.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 06/2010; 6(2):240-6. · 3.29 Impact Factor
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ABSTRACT: Transcatheter patent foramen ovale (PFO) closure might be effective in improving migraines. To assess the efficacy of PFO closure in migraineurs with a moderate to large right-to-left shunt and instrumental evidence of embolic cerebral damage, 76 highly symptomatic migraineurs were prospectively investigated. The presenting clinical syndrome was stroke in 16 patients, repeated transient ischemic attack in 32 patients, and lone migraine associated with cerebral ischemic lesions on magnetic resonance imaging in 28 patients. Migraine severity was assessed before PFO closure and monthly for 6 months after discontinuation of antiplatelet therapy. At the end of 12 months of follow-up, the averaged postprocedural total score was compared with the baseline score. Transcatheter PFO closure was successful in all patients, and the 12-month PFO closure rate was 97%. The baseline total migraine score was similar in patients with stroke, transient ischemic attack, and lone migraine (6.8 +/- 1.6, 6.7 +/- 1.4, and 6.9 +/- 1.7 respectively, p = NS). After a mean follow-up of 13.7 +/- 2.4 months, no recurrent cerebrovascular episodes had occurred. At the end of the follow-up period, a significant reduction in the total migraine score was observed in all groups, regardless of the initial clinical presentation. Migraine was completely abolished in 35 patients (46%), improved in 27 (36%), and unchanged in 14 (18%). The proportion of patients with migraine suppression and improvement was similar in the 3 groups. In conclusion, in highly symptomatic migraineurs with previous ischemic cerebral events and instrumental evidence of cerebral embolism, transcatheter PFO closure can result in improvement of migraine severity in a high percentage of patients.
The American journal of cardiology 09/2009; 104(3):434-9. · 3.58 Impact Factor
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C Pristipino,
C Trani,
M S Nazzaro,
A Berni,
G Patti,
R Patrizi,
B Pironi,
P Mazzarotto, G Gioffrè,
G G L Biondi-Zoccai,
G Richichi
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ABSTRACT: To obtain a "snapshot" view of access-specific percutaneous cardiovascular procedures outcomes in the real world.
Multicentre, prospective study performed over a 30-day period.
Nine hospitals with invasive cardiology facilities, reflecting the contemporary state of healthcare.
Unselected consecutive sample of patients undergoing any percutaneous cardiovascular procedure requiring an arterial access.
Percutaneous cardiovascular procedures by radial or femoral access
The primary outcome was the combined incidence of in-hospital (a) major and minor haemorrhages; (b) peri-procedural stroke; and (c) entry-site vascular complications. The secondary outcome was the combined incidence of in-hospital death and myocardial infarction/reinfarction. For analysis purposes, outcomes were allocated to arterial access-determined study arms on an intention-to treat basis. Multivariable analysis adjusted using propensity score was performed to correct for selection bias related to arterial site.
A total of 1052 patients were enrolled: 509 underwent radial access and 543 femoral access. In both groups, 40% underwent a coronary angioplasty. Relative to femoral access, radial access was associated with a lower incidence both of primary (4.2% vs 1.96%, p = 0.03, respectively) and secondary endpoints (3.1% vs 0.6%, p = 0.005, respectively). Multivariate analysis, adjusted for procedural and clinical confounders, confirmed that intention-to-access via the radial route was significantly and independently associated with a decreased risk both of primary (OR 0.37, 95% CI 0.16 to 0.84) and secondary endpoints (OR 0.14, 95% CI 0.03 to 0.62).
Our study indicates strikingly better outcomes of percutaneous cardiovascular procedures with radial access versus femoral access in contemporary, real-world clinical settings.
Heart (British Cardiac Society) 12/2008; 95(6):476-82. · 4.22 Impact Factor
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Pietro Mazzarotto,
Christian Pristipino,
Francesco Burzotta,
Roberto Serdoz,
Andrea Berni,
Gennaro Sardella,
Alessandro Danesi,
Germano Di Sciascio,
Leone Dino Zingales,
Paolo Loschiavo,
Alessandro Sciahbasi, Gaetano Gioffrè,
Francesco Gemelli
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ABSTRACT: The follow-up strategies after percutaneous coronary intervention (PCI) have relevant clinical and economic implications. The purpose of this prospective observational multicenter study was to evaluate the effect of clinical, procedural and organizational variables on the execution of functional testing (FT) and planned coronary angiography (CA) after PCI, and to assess the impact of American College of Cardiology (ACC)/American Heart Association (AHA) guidelines on clinical practice.
Four hundred twenty consecutive patients undergoing PCI were categorized as class I, IIB and III indications for follow-up FT according to ACC/AHA guidelines recommendations. Furthermore, all patients were grouped according to the presence or absence of FT and/or planned CA over 12 months after PCI. Multivariable analysis was used to assess the potential predictors of test execution.
During the 12-month follow-up at least one test was performed in 72% of patients with class I indication, 63% of patients with class IIB indication and 75% of patients with class III indication (p=ns). A total of 283 patients (67%) underwent testing. The use of tests was associated with younger age (R.R. 0.94, C.I. 0.91+/-0.97, p<0.001), a lower number of diseased vessels (R.R. 0.60, C.I. 0.43+/-0.84, p=0.003), follow-up by the center performing PCI (R.R. 2.64, C.I. 1.43+/-4.86, p=0.002), and the specific center at which PCI was performed. Most asymptomatic patients completed their testing prematurely with respect to the risk period for restenosis.
The use of FT and planned CA after PCI is unrelated to patient's symptom status, and depends on patient's age and logistics. ACC/AHA guidelines have no influence in clinical practice, and test timing is not tailored to the risk period for restenosis.
International journal of cardiology 08/2008; 137(2):151-7. · 7.08 Impact Factor
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Journal of Cardiovascular Medicine 04/2008; 9(3):325-6. · 1.51 Impact Factor
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Fabrizio Tomai,
Bernhard Reimers,
Leonardo De Luca,
Alfredo R Galassi,
Achille Gaspardone,
Anna S Ghini,
Valeria Ferrero,
Luca Favero, Gaetano Gioffrè,
Francesco Prati,
Corrado Tamburino,
Flavio Ribichini
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ABSTRACT: It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES).
We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up.
A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 +/- 0.4 vs. 0.50 +/- 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1-5.0]; P = 0.03).
SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.
Diabetes care 02/2008; 31(1):15-9. · 8.09 Impact Factor
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Francesco Burzotta,
Enrico Romagnoli,
Alessandro Manzoli,
Christian Pristipino,
Flavia Belloni,
Gennaro Sardella,
Stefano Rigattieri, Gaetano Gioffrè,
Pietro Mazzarotto,
Francesco Summaria,
Antonio Parma,
Alessandro Danesi,
Francesco Prati,
Carlo Trani
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ABSTRACT: Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population.
We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization).
The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.
American heart journal 04/2007; 153(3):377.e1-5. · 4.65 Impact Factor
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ABSTRACT: Sirolimus-eluting stents (SESs), paclitaxel-eluting stents (PESs), and dexamethasone-eluting stents (DEXs) have anti-inflammatory properties; thus, the decreased in-segment restenosis rate observed with the use of these stents might be related to a weaker postprocedural inflammatory response. One hundred sixty consecutive patients with stable coronary artery disease who underwent successful single-vessel/lesion coronary artery stenting were prospectively studied. Thin-strut bare metal stents were deployed in 39 patients, SESs in 30, PESs in 61, and DEXs in 30. The 4 groups were similar with respect to demographic and angiographic variables and prevalence of risk factors. C-reactive protein (CRP) was measured at baseline and 24 and 48 hours after the procedure. Maximal increase in CRP was calculated as the increase in CRP at 48 hours/CRP compared with baseline. Angiographic follow-up was performed after 12.9 +/- 1.3 months or sooner, if needed, on the basis of clinical evidence. All patients presented a postprocedural increase in CRP that peaked at 48 hours (median 10.0 mg/L). Maximal CRP increase was similar across the 4 groups (medians 3.5 mg/L in the bare metal stent group, 3.6 mg/L in the SES group, 4.0 mg/L in the PES group, 3.5 mg/L in the DEX group, p = 0.45). Incidences of angiographic binary restenosis (>50% lumen diameter decrease) were 20.5% in the bare metal stent group, 3.3% in the SES group, 4.9% in the PES group, and 36.6% in the DEX group (p = 0.0004 for SES and PES groups vs bare metal stent and DEX groups). Postprocedural increase in CRP was significantly correlated with clinical and angiographic outcomes. In conclusion, the acute postprocedural systemic inflammatory response induced by drug-eluting stent implantation appears to be similar to that induced by bare metal stents. However, the restenosis rate is lower for SESs and PESs than for DEXs and bare metal stents. Thus, the decreased incidence of stent restenosis that was observed after SES and PES deployment is unlikely to be related to a decreased acute systemic inflammatory response, but rather to an increased local resistance to inflammatory mediators.
The American Journal of Cardiology 05/2006; 97(9):1311-6. · 3.37 Impact Factor
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Fabrizio Tomai,
Patrizio Polisca,
Anna S Ghini,
Achille Gaspardone,
Francesco Versaci,
Alessandro Furgeri,
Igino Proietti, Gaetano Gioffrè,
Filippo Crea,
Luigi Chiariello,
Pier A Gioffrè
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ABSTRACT: The immediate effects of balloon mitral valvuloplasty (BMV) on left ventricular (LV) function in patients with mitral stenosis are still controversial. The aim of this study was to investigate the mechanisms and potential clinical, echocardiographic and hemodynamic predictors of transient LV dysfunction occurring in patients with mitral stenosis early after successful percutaneous BMV.
Sixty patients without residual mitral regurgitation were divided into two groups according to the changes in the left atrial (LA) pressure 15 min after successful BMV: 18 patients (group A) did not present with any reduction in LA pressure, and underwent nitroglycerin administration (0.4 mg, sublingually). The remaining 42 patients (group B) presented with a decrease in LA pressure.
At baseline, both the mitral valve gradient and area assessed at echocardiography and during cardiac catheterization were similar in groups A and B. Group A patients presented with, however, higher LV early- and end-diastolic pressures and peak V waves during cardiac catheterization both prior to and 15 min after BMV than group B patients (all p values < 0.05). In group A, nitroglycerin administration was associated with a decrease in LV end-diastolic pressure (p = 0.049), LA pressure (p < 0.001), and peak V wave (p < 0.001) that was still persistent 30 min after its administration, reaching values similar to those observed in group B early after BMV. At multivariate analysis, the only independent predictors of LV dysfunction early after BMV were found to be LV early- (p = 0.015) and end-diastolic (p = 0.023) pressures at baseline and the Wilkins' score (p = 0.004).
After successful BMV a transient lack of LV adaptation to the increased LV preload resulting in a persistently elevated LA pressure is predicted by higher baseline LV diastolic filling pressures and higher Wilkins' scores. It is promptly and steadily reversed by nitroglycerin administration through a transient LV unloading, thus allowing a correct hemodynamic evaluation of the immediate results of the procedure.
Italian heart journal: official journal of the Italian Federation of Cardiology 08/2004; 5(8):612-7.
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ABSTRACT: Objectives. This study attempted to establish whether bamiphylline, a selective antagonist of A1 adenosine receptors, prevents the algogenic effects of adenosine in humans.Background. Experimental findings indicate that the sympathoexcitatory response elicited by adenosine is mediated by A1 receptors.Methods. An intrailiac infusion of increasing doses (from 125 to 2,000 μg/min) of adenosine was given to 20 patients. Adenosine infusion was then repeated after intrailiac infusion of either bamiphylline or saline solution. In 14 other patients with angina, increasing doses of adenosine (from 108 to 1,728 μg/min) were infused into the left coronary artery. Adenosine infusion was then repeated after the intravenous infusion of either bamiphylline or placebo. Coronary blood flow velocity was monitored by a Doppler catheter. Data relative to pain severity are expressed as median and all other data as mean value ± 1 SD.Results. Bamiphylline prolonged the time to pain onset caused by the intrailiac adenosine infusion from 444 ± 96 to 749 ± 120 s (p < 0.001) and reduced pain severity from 45 to 24 mm (p < 0.01). After placebo infusion, the time to pain onset and pain severity were similar to that of baseline (428 ± 112 vs. 430 ± 104 s, p = 0.87 and 44 vs. 43 mm, p = 0.67, respectively). Bamiphylline prolonged the time to pain onset caused by intracoronary adenosine infusion from 519 ± 128 to 603 ± 146 s (p < 0.01) and reduced pain severity from 58 to 28 mm (p < 0.02). After placebo infusion, the time to pain onset and pain severity were similar to that at baseline (542 ± 87 vs. 551 ± 79 s, p = 0.14 and 55 vs. 50 mm, p = 0.61). Maximal coronary blood flow velocities before and after bamiphylline administration were similar (47 ± 22 vs. 49 ± 24 cm/s, p = 0.36) as well as before and after placebo administration (40 ± 20 vs. 41 ± 20 cm/s, p = 0.07).Conclusions. Bamiphylline reduces adenosine-induced muscular and cardiac pain but does not affect adenosine-induced coronary vasodilation. These findings indicate that at the dose used in this study, bamiphylline does not detectably block vascular A2-receptor-mediated adenosine effects in humans, which suggests that the muscular and cardiac algogenic effects of adenosine are mediated mainly by A1 receptors.
Journal of the American College of Cardiology.
